Delivery system for medical device

ABSTRACT

A system for delivery of a medical device to a target site within the body of a patient includes an introducer sheath, and a delivery assembly receivable within a passageway of the sheath. The delivery assembly comprises an inner tubular and an outer tubular member. At least a distal portion of the inner tubular member has a diameter such that the medical device is receivable thereover. The outer tubular member is generally coaxial with the inner tubular member, and has a length such that the outer tubular member distal end terminates proximal to the inner tubular member distal portion. The outer tubular member has a first outer diameter at the proximal end and extends for a length of the outer tubular member to a first diameter boundary point. The outer tubular member has a gradual inward taper in the distal direction from the boundary point to a second outer diameter, and has an abrupt outward taper in the distal direction from the second diameter to the first diameter.

BACKGROUND

1. Technical Field

The present invention relates to a delivery system for transporting amedical interventional device to a target site within the body of apatient. More particularly, the invention relates to a system of coaxialtubular members for delivering a medical device, such as a stent, into adesignated lumen in the body of a patient to establish, or maintain,patency of the lumen.

2. Background Information

In modern medicine, interventional devices are often percutaneouslyintroduced into the body of a patient via a suitable delivery apparatus,and delivered to a target site within the body for a medical purpose.One common example of a medical interventional device introduced in thismanner is a stent. A stent is typically inserted into the lumen of avessel or other bodily passageway to reinforce, repair, or otherwiseprovide support to establish or maintain the patency of the lumen. Forexample, when a patient suffers from atherosclerosis (hardening of thearteries), a stent may be placed in a coronary or a peripheral artery ata location where the artery is weakened, damaged or otherwisesusceptible to collapse. The stent, once in place, reinforces thatportion of the artery, thereby restoring normal blood flow through thevessel.

One form of stent which is particularly desirable for implantation inarteries and other body lumens is a cylindrical stent which is radiallyexpandable upon implantation from a smaller first diameter to a largersecond diameter. Radially expandable stents are typically loaded onto,or into, a delivery catheter, and fed internally through the arterialpathways of the patient until the unexpanded stent reaches the targetsite. Radially expandable stents are normally of two general types. Onetype, generally referred to as a “balloon-expandable” stent, is fittedin a compressed state over an uninflated balloon at the distal endportion of the delivery catheter. Once the catheter reaches the targetsite, the balloon is inflated by transmitting an inflation fluid througha lumen in the delivery catheter to the interior of the balloon. Uponinflation, the balloon exerts a radial pressure on the stent, therebycausing the compressed stent to radially expand to a larger diameter.Following expansion, the stent exhibits sufficient radial rigidity toremain in the expanded condition after the balloon has been deflated andthe catheter has been removed.

The other type of radially expandable stent, generally referred to as a“self-expanding” stent, is formed from a resilient or shape memorymaterial which is capable of self-expanding from a compressed state toan expanded state without the application of a radial outwardly-exertedforce on the stent. Typically, a self-expanding stent is loaded into adelivery device that restrains the stent in the compressed state. Oncethe delivery device is directed to the target site, an ejectionmechanism, such as a pusher, is employed to eject the stent from thedistal end of the delivery device. Alternatively, an outer sheath of thedelivery device is withdrawn such that it no longer covers the stent. Ineither event, once the stent is freed from the restraints of the device,it self-expands to the desired diameter.

The use of radially expandable stents advantageously allows thephysician to insert relatively smaller diameter medical devices to propup, reinforce or otherwise support relatively larger diameter vessels.However, the delivery of such stents to the target site has at timesproven to be problematic. For example, the structure of a conventionaldelivery catheter may cause the catheter shaft to be subject to stressrisers as it traverses the vessel. Stress risers comprise weakened orhigh stress segments of the catheter which may cause the catheter shaftto undesirably bend or otherwise fail during passage through the vessel.In a delivery system for a self-expanding stent that includes coaxialcatheters, such high stress segments may occur, for example, at thepoint where the inner catheter meets the outer catheter. This typicallyoccurs when the delivery system traverses a tortuous pathway in the bodyof the patient. In some cases, such as the bifurcation into the iliacs,the catheter is required to go around a high angle bend. In theseinstances, kinking and decreased trackability are prone to occur due tothe high stress in the system as it attempts to traverse the high anglebend.

It is desired to provide a delivery system for a stent or otherinterventional medical device that avoids the problems of prior artdevices.

SUMMARY

The problems of the prior art are addressed by the inventive deliverysystem. In one form thereof, the invention comprises an assembly for usein the delivery of a medical device to a target site within the body ofa patient. The assembly comprises an inner tubular member having adistal portion sized to receive the medical device thereover. An outertubular member is coaxial with the inner tubular member, and has alength such that the distal end of the outer tubular member distal endterminates proximal to the inner tubular member distal portion. Theouter tubular member has a first outer diameter at its proximal end, anda gradual inwardly tapered portion in a distal direction to a secondouter diameter. The outer tubular member then has an abrupt outwardtaper in the distal direction from the second diameter.

In another form thereof, the invention comprises a system for deliveryof a medical device to a target site within the body of a patient. Thedelivery system includes an introducer sheath having a proximal end, adistal end, and a passageway extending therebetween. The introducersheath has a length sufficient for insertion through a pathway in thebody of the patient from an entry site to the target site. A deliveryassembly is receivable within the sheath passageway for carrying themedical device. The delivery assembly comprises an inner tubular memberhaving a proximal end and a distal end, at least a distal portion of theinner tubular member having a diameter such that the medical device isreceivable thereover, and an outer tubular member having a proximal endand a distal end. The outer tubular member is generally coaxial with theinner tubular member and has a length such that the outer tubular memberdistal end terminates proximal to the inner tubular member distalportion. The outer tubular member has a first outer diameter at theproximal end and extends for a length of the outer tubular member to afirst diameter boundary point. The outer tubular member has a gradualinward taper in the distal direction from the boundary point to a secondouter diameter, and has an abrupt outward taper in the distal directionfrom the second diameter.

In still another form thereof, the invention comprises a deliveryassembly for use in delivering a medical device to a target site withinthe body of a patient. The delivery assembly comprises an inner tubularmember and an outer tubular member. At least a distal portion of theinner tubular member has a diameter such that the medical device isreceivable thereover in a compressed condition. The outer tubular memberis generally coaxial with the inner tubular member, and has a lengthsuch that the distal end of the outer tubular member terminates proximalto the inner tubular member distal portion. The outer tubular member hasa first outer diameter at its proximal end, and has a gradual inwardlytapered portion in a distal direction to a second outer diameter. Aholder band is disposed over the outer tubular member second diameter.The holder band is sized and arranged to maintain a position of themedical device on the inner tubular member.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a longitudinal sectional view of a delivery system accordingto one embodiment of the present invention;

FIG. 2 is an enlarged view of a portion of FIG. 1;

FIG. 3 is a longitudinal sectional view of the inner delivery assemblyof the delivery system of FIG. 1;

FIG. 4 is an enlarged view of the distal end portion of the outer tubeof the inner delivery assembly;

FIG. 5 is a longitudinal sectional view of an alternative embodiment ofan inner delivery assembly for use in a delivery system; and

FIG. 6 is an enlarged view of a portion of the inner delivery assemblyof FIG. 5.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERREDEMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings, and specific language will be used to describe the same.It should nevertheless be understood that no limitation of the scope ofthe invention is thereby intended, such alterations and furthermodifications in the illustrated device, and such further applicationsof the principles of the invention as illustrated therein beingcontemplated as would normally occur to one skilled in the art to whichthe invention relates.

In the following discussion, the terms “proximal” and “distal” will beused to describe the opposing axial ends of the delivery system, as wellas the axial ends of various component features. The term “proximal” isused in its conventional sense to refer to the end of the system (orcomponent thereof) that is closest to the operator during use of thesystem. The term “distal” is used in its conventional sense to refer tothe end of the system (or component thereof) that is initially insertedinto the patient, or that is closest to the patient during use.

FIG. 1 is a longitudinal sectional view of a delivery system 10according to one embodiment of the present invention. FIG. 2 is anenlarged view of a portion of the delivery system of FIG. 1. Asillustrated, delivery system 10 comprises an introducer sheath 12, andan inner delivery assembly 14. In the embodiment shown, inner deliveryassembly 14 comprises coaxial outer 16 and inner 18 tubular members. Thefigures also illustrate the presence of a medical interventional device,such as stent 20, that is loaded into the delivery system at a distalend of inner delivery assembly 14. A conventional handle (not shown) maybe provided at the proximal end of the system.

Introducer sheaths are well known in the medical arts. Optimally, anintroducer sheath should be capable of traversing tortuous pathways inthe body of the patient without kinking. This generally necessitatesthat the sheath have sufficient flexibility to negotiate high anglebends, such as the bifurcation into the iliacs. At the same time, thesheath should have sufficient trackability to enable it to enter, andpass into, the target area.

A preferred introducer sheath for use in the inventive system is theFLEXOR® introducer sheath, available from Cook Incorporated, ofBloomington, Ind. The FLEXOR® sheath includes an inner lubricious liner,an outer polymeric jacket, and a coil reinforcement between the innerand outer layers. Typically, the sheath comprises one or morelongitudinal segments of decreasing durometer in the distal direction.This sheath provides very favorable flexibility without kinking orcompression. One or more radiopaque bands or markers may be incorporatedwithin the sheath material to allow precise location of the sheath'sdistal tip for positioning accuracy. Those skilled in the art willappreciate that other known introducer sheaths may also be suitable fora particular purpose. The length of the introducer sheath will typicallybe between about 80 and 150 cm. Preferably, the length of the introducersheath will be between about 110 and 130 cm, and more preferably, about125 cm. Those skilled in the art will appreciate, however, that alldimensions provided herein are intended as examples only, and thatsheaths and inner delivery assemblies of different dimensions may besubstituted for a particular use.

FIG. 3 is a longitudinal sectional view of the inner delivery assembly14 of delivery system 10. For illustrative purposes, a stent 20 has beenloaded onto the distal end of assembly 14. Coaxial outer and inner tubes16, 18 are preferably immovable relative to each other, or at most, onlyminimally movable such that the relative positioning of the tubes asshown in the figures is substantially maintained during use of deliverysystem 10. Outer and inner tubes 16, 18 can be rendered substantiallyimmovable, for example, by utilizing an adhesive or other attachmentmechanism that connects the tubes at their respective proximal ends.Alternatively, the adhesive or other attachment mechanism can be appliedanywhere along the length of the outer and inner tubes in a mannersufficient for maintaining the respective relative positionssubstantially as shown in the figure.

Inner tube 18 may have a length the same as, or substantially similarto, the length of the introducer sheath. Inner tube 18 includes apassageway 22 extending therethrough having a diameter sufficient toaccommodate a wire guide (not shown). A distal seat portion 24 of innertube 18 is sized for seating stent 20 on an outer surface thereof.Typically, a soft polymeric tip 19 is positioned at the distal end ofinner tube 18 to ease entry into the body.

Outer tube 16 of inner delivery assembly 14 has a length less than thelength of inner tube 18. Thus, for example, when a 125 cm introducersheath is used, the length of inner tube 18 may also be about 125 cm,and the length of outer tube 16 may be about 117 cm. The difference inlength between inner tube 18 (125 cm) and outer tube 16 (117 cm)represents the length of seat portion 24 for stent 20. In this case,seat portion 24 and stent 20 each have a length of about 8 cm. Thecomponents of delivery system 10 can, of course, be formed to have otherlengths so that stents or other medical interventional devices havinglengths other than 8 cm can also be delivered via the inventive deliverysystem 10.

Beginning at proximal end 17 and extending in the distal direction forthe major part of its length, outer tube 16 of inner delivery assembly14 preferably has a generally uniform outer diameter, referred to hereinas the “nominal” diameter of tube 16. As described herein, a “major”part of the length of outer tube 16 refers to a length that exceedsone-half of the overall length of outer tube 16. Preferably, the “major”length of outer tube 16 refers to a length of at least about 75% of thelength of the tube. The outer profile of a distal portion A (FIG. 3) ofouter tube 16 is modified when compared to the nominal diameter of itsmajor length. For the delivery system having the dimensions providedhereinabove, the distal most portion A having the modified profilerepresents approximately the distal most 16 cm of the outer tube 16.Beginning at the proximal boundary 40 of portion A (which has thenominal outer diameter), and extending in a distal direction therefrom,the outer diameter of outer tube 16 has a gradual inward taper for adistance of between about 10 and 20 cm, preferably about 15 cm, to aminimum diameter point 42. This inwardly tapering portion is designatedin FIG. 3 as portion B. There is then a short, or abrupt, outward taperback (over a distance of approximately 0.2 cm) to the nominal diameter.The nominal diameter thereafter extends substantially in the distaldirection the remainder (approximately 0.8 cm) of portion C until itterminates in outward flared portion 44. As described herein, a “gradualinward taper” is one that extends from a larger diameter over arelatively large length to a smaller diameter. An “abrupt outward taper”is one that extends from a smaller diameter over a relatively shortlength, typically not more than about 1 cm, to a larger diameter.

Although it is preferred that outer tube 16 maintains the nominaldiameter for the major part of its length prior to the gradual inwardtaper, this is not necessary in all instances. If desired, a moregradual inward taper of tube 16 that commences from a point proximal tothat of boundary 40 up to proximal end 17 maybe substituted. Similarly,although it is preferred that the abrupt outward taper occur over arelatively short length (such as 0.2 cm in the example provided), thisis not necessary in all instances, and a somewhat less abrupt outwardtaper may be substituted. Preferably, however, the respective “gradual”and “abrupt” tapers will be in general proportion to those of the inwardand outward tapers recited in the example provided.

Outer tube 16 is configured such that it includes a shoulder 28 at itsdistal end. Preferably, the distal most extension of portion C is alsoprovided with the slight outward flare 44. This is best shown in FIG. 4.As a result, when inner delivery assembly 14 is received in introducersheath 12 as shown in FIG. 1, the radial extension of flared portion 44substantially butts against the inner surface of the introducer sheath.In this manner, shoulder 28 and flare 44 act in the nature of a holding,or restraining, band to prevent proximal movement or drifting of stent20 as introducer sheath 12 is withdrawn in the proximal direction duringdeployment of the stent.

Typically in a coaxial catheter assembly utilized in a delivery system,a high stress point is created where the inner tube meets the outertube. This is particularly true in the vicinity of the distal portion ofthe outer tube. This is due, in part, to the stiffness of the combinedtubes being greater than the stiffness of the single inner tube, and, inpart, to the stiffness of the medical interventional device, such asstent 20, seated on the inner tube. As stated, when the catheterassembly is required to go around a high angle bend, such as theaforementioned bifurcation into the iliacs, kinking and decreasedtrackability are prone to occur due to the high stress point describedabove, as well as any other stress risers that may form or otherwise bepresent. In the embodiment of the inventive arrangement described, thestress at the high stress point is reduced by providing the gradualinward taper of the outer tube diameter to the smaller diameter in thevicinity of the distal end of the inner delivery assembly, and thenproviding the abrupt outward taper in the inverse direction. Thisarrangement will distribute the stress more evenly, and improvetrackability.

Tapered portion B may be formed in outer tube 16 by any conventionalmeans. Preferably, tube 16 is ground to the desired taperedconfiguration, such as with use of a conventional grinder that can beprogrammed to grind different profiles, a process often referred to ascenterless grinding. Alternatively, other known means for forming atapered catheter, such as extrusion, may be employed. The distal flare44 of tube 16 may be formed by conventional means, such as by heatingthe portion to be flared (e.g., via a conventional flare gun) andforming the desired flare on the heated portion. The flare need not haveany specific configuration, as long as the configuration is suitable foracting as a pusher or holder against the stent, such that proximal driftof the stent is inhibited upon withdrawal of the introducer sheath. Ingeneral, it is preferred to shield as much of the proximal end of thestent area as possible with the flare.

The dimensions of the introducer sheath 12 and the outer and inner tubes16, 18 will, of course, depend upon the intended use of the deliverysystem 10. The following non-limiting example is provided to illustratethe relative dimensions of the various component features for arepresentative use. In this example, the length of the introducer sheathis 125 cm. The outer diameter (OD) of the sheath will, of course, bedependent upon the vessel to be traversed. In most cases the OD of theintroducer sheath will be between about 0.069 and 0.10 inch (1.75 and2.54 mm), and in the example provided herein, about 0.092 inch (2.34mm). The inner diameter (ID) of the sheath will, in most cases, bebetween about 0.0535 and 0.090 inch (1.36 and 2.29 mm), and in theexample described herein, about 0.076 inch (1.93 mm). As stated, thesedimensions are merely exemplary of possible dimensions for a particularuse. Those skilled in the art can readily select appropriate dimensionsfor a specific use.

With reference to the components of the inner delivery system 14, the IDof the inner tube 18 may be about 0.040 inch (1.02 mm), or large enoughsuch that a wire guide can be accommodated therethrough. The 0.040 inchID is large enough to accommodate a standard wire guide of about 0.035inch (0.89 mm) diameter. The OD of the inner tube may be about 0.051inch (1.30 mm). The nominal OD of outer tube 16 may be about 0.071 inch(1.80 mm), and the ID of the tube may be about 0.058 inch (1.47 mm). Theminimum OD of the outer tube at point 42 of maximum taper may be about0.064 inch (1.63 mm). The maximum OD at flared portion 44 may be about0.075 inch (1.91 mm), or in other words, only slightly less than the0.076 inch (1.93 mm) ID of the introducer sheath. Once again, thoseskilled in the art will appreciate that these dimensions are merelyexemplary of possible dimensions for a particular use, and thatappropriate dimensions can be readily selected for a specific intendeduse.

One specific example of a taper of outer tube 16 has been providedabove. In that non-limiting example, the outer diameter of outer tube 16has a gradual inward taper (portion “B”) for a distance of about 15 cm,to a minimum diameter point 42. There is then a short outward taper ofapproximately 0.2 cm to the nominal diameter, which thereafter extendssubstantially in the distal direction the remainder (approximately 0.8cm) of portion C. Those skilled in the art will appreciate that thesedimensions are also merely exemplary of possible dimensions for aparticular use, and that appropriate dimensions can be readily selectedfor a specific intended use. Typically, virtually any taper into thenominal diameter of the outer tube will provide at least some enhancedflexibility to the tube, and serve to distribute the stress more evenlythan before. A skilled artisan may utilize routine experimentation todetermine an optimal taper for a particular use, which taper may includea more, or less, gradual inward taper than described in the exampleabove, and a more, or less, gradual outward taper. Such a taper will, inmany instances, be dependent upon the respective compositions of thesheath and inner delivery assembly, as well as the anticipated degree ofbend of the sheath and assembly as they pass through one or more bendsin a tortuous body passageway.

Outer and inner tubes 16, 18 of inner delivery assembly 14 arepreferably formed of a composition having sufficient strength,flexibility, and resistance to compression to traverse tortuous areas ofthe anatomy. One particularly preferred composition is PEEK(polyetheretherketone). PEEK is a particularly favored composition formedical use based upon the properties recited above, as well as itsbiocompatibility and resistance to degradation under extreme conditions.Those skilled in the art will appreciate, however, that othercompositions may also be suitable for a particular application.Non-limiting examples of other suitable catheter compositions includenylon (polyamide), polyether block amides, and PET (polyethyleneterephthalate).

FIGS. 5 and 6 illustrate an alternative inner delivery assembly 114 foruse in the inventive delivery catheter 10. Introducer sheath 12 has beenomitted from these figures to better illustrate the features of theinner delivery assembly. FIG. 5 is a longitudinal sectional view of theinner delivery assembly 114. FIG. 6 is an enlarged view of a portion ofFIG. 5. In this embodiment, inner delivery assembly 114 comprisescoaxial outer 116 and inner 118 tubes. The figures also illustrate thepresence of a stent 20 that is loaded into the delivery system at adistal end of inner delivery assembly 114.

Inner tube 118 includes a passageway 122 extending therethrough having adiameter sufficient to accommodate a wire guide (not shown). A distalportion 124 of inner tube 118 is sized for seating stent 20 on an outersurface thereof. Outer tube 116 of inner delivery assembly 114 has alength less than the length of inner tube 118, which difference inlength represents the length of distal seat portion 124 for stent 20.The components of inner delivery assembly 114 not specifically describedare generally the same as or similar to corresponding components in thepreviously-described inner delivery assembly 14.

In the preferred embodiment shown, outer tube 116 extends in the distaldirection from proximal end 117 at a generally uniform “nominal”diameter for the major part of its length. The outer profile of a distalportion X of outer tube 116 (FIG. 5) is modified when compared to thenominal diameter of its major length. In this embodiment, the distalmost portion X begins at point 140, and exhibits a gradual inward taperto a minimum diameter at the distal end 142 of outer tube 116.Alternatively, the taper may commence at a point proximal to point 140if an even more gradual taper is desired.

A holder band 150 for the medical device, such as stent 20, is fittedover the distal portion of outer tube 116. In the preferred embodimentshown in FIG. 6, holder band 150 has an inner diameter that increasesfrom a smaller ID at the distal end 152 to a larger ID at proximal end154. Preferably, at least a portion of the distal length of holder band150 extends distal of outer tube distal end 142. In a preferredembodiment, at least a portion of the interior surface of holder band150 has an outward taper that substantially corresponds to the inwardtaper of outer tube 116. When fitted onto inner delivery assembly 114 asshown, the outer diameter of holder band 150 will preferably besubstantially the same as the nominal outer diameter of outer tube 116.The respective outer diameters of the outer tube and the holder bandwill preferably be similar to, but slightly smaller than, the innerdiameter of the introducer sheath (not shown). As a result, the outerdiameter of the holder band will be as close to the inner diameter ofthe introducer sheath as possible, without causing interference orfriction upon relative movement with the introducer sheath.

Holder band 150 terminates in the distal direction in a shoulder 156.Shoulder 156 is preferably sized and configured to inhibit stent 20 fromprotruding or otherwise drifting in the proximal direction beyondshoulder 156 upon withdrawal of the introducer sheath during deploymentof the stent, in the same manner as shoulder 28 in the previousembodiment. The holder band need not be formed to have the identicalconfiguration described herein, as long as the selected configurationprovides enhanced flexibility to the overall assembly, and will sufficeto maintain, or hold, the position of the stent as described. Use of aseparate element, such as the holder band, may provide enhancedflexibility in a particular case when compared to the use of an integraltube as described in the previous embodiments. Utilizing a separateelement also provides the ability to use different materials for thisportion of the assembly, such as a more flexible composition, ifdesired.

Holder band 150 is preferably formed of a flexible polymeric materialsuch as nylon. Other known materials, such as polymers and non-ferrousmetals, having favorable compression strength and flexibility may besubstituted. The tapered portion may be formed in outer tube 116 in thesame manner in which the taper is formed in outer tube 16. A flare maybe formed at the distal end of the holding band in the same manner asthe flare in outer tube 16.

While these features have been disclosed in connection with theillustrated preferred embodiments, other embodiments of the inventionwill be apparent to those skilled in the art that come within the spiritof the invention as defined in the following claims.

1-15. (canceled)
 16. A delivery assembly for use in delivering a medicaldevice to a target site within the body of a patient, comprising: aninner tubular member having a proximal end and a distal end, at least adistal portion of said inner tubular member having a diameter such thatsaid medical device is receivable thereover in a compressed condition;an outer tubular member having a proximal end and a distal end, saidouter tubular member generally coaxial with the inner tubular member andhaving a length such that said outer tubular member distal endterminates proximal to said inner tubular member distal portion, saidouter tubular member having a first outer diameter at said proximal endand having a gradual inwardly tapered portion in a distal direction to asecond outer diameter; and a holder band having a proximal end and adistal end, at least a portion of said holder band disposed over saidouter tubular member second diameter, said holder band sized andarranged to maintain a position of said medical device on said innertubular member.
 17. The delivery assembly of claim 16, wherein saidfirst outer diameter extends for a major length of said outer tubularmember to a first diameter boundary point, said outer tubular memberhaving said gradual inward taper in the distal direction from saidboundary point to said second outer diameter.
 18. The delivery assemblyof claim 17, wherein said holder band has an outward taper from saiddistal end to said proximal end, at least a portion of said outwardtaper corresponding to said outer tubular portion inward taper.
 19. Thedelivery assembly of claim 16, wherein the distal end of said holderband comprises a shoulder for inhibiting proximal movement of saidmedical device.
 20. The delivery assembly of claim 16, wherein saidholder band has a greater flexibility than a flexibility of said outerand inner tubular members.